Despite criticism in some areas that treatments are not being approved quickly enough, the US Food and Drug Administration notes that it gave the green light to 35 novel medicines in the fiscal year ended September 30.
That matches the agency’s performance in fiscal 2011 and the FDA noted that an approval was granted “often more quickly than it was done anywhere else in the world”. Of the 32 novel drug approvals that the agency was able to compare to approvals in other countries, 75% were first given the thumbs-up in the USA.
Some 77% of the 35 were approved on the first cycle of review, without the need for additional information that lengthens approval time and 34 out of the 35 met the target dates agreed to under the Prescription Drug User Fee Act. The FDA also noted that it expedited the review and approval of over half of these new medicines – of the 12 drugs that received a fast-track designation, 75% were approved on the first cycle. Of the 10 fast-track drugs for which the FDA was able to make comparisons to approvals in other countries, 100% were given the go-ahead in the USA first.
Of the approvals, the FDA made special mention of “a groundbreaking treatment for a form of cystic fibrosis”, Vertex Pharmaceuticals’ Kalydeco (ivacaftor) and the first drugs to treat advanced basal cell carcinoma, Roche’s Erivedge (vismodegib), and myelofibrosis, Incyte’s Jakafi (ruxolitinib).
